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GUIDANCE DOCUMENT

Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products September 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-1837
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of New Drugs

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Statement of Identity and Strength--Content and Format of Labeling for Human Nonprescription Drug Products.” This draft guidance provides recommendations for the content and format of the required statement of identity on the labeling of human nonprescription drug products. This draft guidance also provides recommendations on the inclusion of the drug product’s strength on the labeling. The recommendations in this draft guidance are intended to help manufacturers, packers, distributors, applicants, relabelers, and sponsors ensure consistent content and format of the statement of identity and strength for all human nonprescription drug products. Consistent content and format of the statement of identity and strength may aid consumers in comparing nonprescription drug products and assist consumers in appropriate self-selection.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-1837.

 
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